TROSPIUM CHLORIDE Film-coated tablet Ref.[9719] Active ingredients: Trospium

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Glenmark Pharmaceuticals Europe Limited, Laxmi House, 2B Draycott Avenue, Harrow, Middlesex HA3 0BU, UK

Product name and form

Trospium chloride 20mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Brownish yellow to light brown round, biconvex film-coated tablets, debossed with “L” on one side and “l” on other side.

Qualitative and quantitative composition

The active ingredient is trospium chloride. Each film-coated tablet contains 20 mg of trospium chloride.

Excipients with known effect: Each film-coated tablet contains 10 mg of lactose monohydrate and 18.5 mg of sucrose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Trospium

Trospium is an antispasmodic, antimuscarinic agent indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Receptor assays showed that trospium has negligible affinity for nicotinic receptors as compared to muscarinic receptors at concentrations obtained from therapeutic doses. Trospium antagonizes the effect of acetylcholine on muscarinic receptors in cholinergically innervated organs. Its parasympatholytic action reduces the tonus of smooth muscle in the bladder.
List of Excipients

Core:

Cellulose microcrystalline
Lactose monohydrate
Maize starch
Povidone
Croscarmellose sodium
Silica colloidal anhydrous
Magnesium stearate

Coating:

Sucrose
Copovidone
Titanium dioxide (E171)
Macrogol 6000
Macrogol 400
Talc
Hypromellose (E464)
Iron oxide yellow (E172)
Iron oxide red (E172)

Pack sizes and marketing

PVC/PVDC-Aluminium blisters in cartons of 30, 50, 60, 100 film-coated tablets per carton.

Not all pack sizes may be marketed.

Marketing authorization holder

Glenmark Pharmaceuticals Europe Limited, Laxmi House, 2B Draycott Avenue, Harrow, Middlesex HA3 0BU, UK

Marketing authorization dates and numbers

PL 25258/0108

25/02/2018

 
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